Trial Outcomes & Findings for Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC) (NCT NCT01550367)
NCT ID: NCT01550367
Last Updated: 2020-01-02
Results Overview
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
1200 mg/d HCQ
|
13
|
|
Overall Study
600 mg/d HCQ
|
17
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measure Analysis Population Description: Rows represent different dosage levels of HCQ.
Baseline characteristics by cohort
| Measure |
Hydroxychloroquine (HCQ) (1,200 mg/d or 600 mg/d) + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d for initial (13) patients, then 600 mg/d for next (17) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d.
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|---|---|
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Age, Continuous
1200 mg/d HCQ
|
58.2 years
n=13 Participants • Measure Analysis Population Description: Rows represent different dosage levels of HCQ.
|
|
Age, Continuous
600 mg/d HCQ
|
56.5 years
n=17 Participants • Measure Analysis Population Description: Rows represent different dosage levels of HCQ.
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Sex: Female, Male
1200 mg/d HCQ · Female
|
4 Participants
n=13 Participants • Rows represent different dosage levels of HCQ.
|
|
Sex: Female, Male
1200 mg/d HCQ · Male
|
9 Participants
n=13 Participants • Rows represent different dosage levels of HCQ.
|
|
Sex: Female, Male
600 mg/d HCQ · Female
|
4 Participants
n=17 Participants • Rows represent different dosage levels of HCQ.
|
|
Sex: Female, Male
600 mg/d HCQ · Male
|
13 Participants
n=17 Participants • Rows represent different dosage levels of HCQ.
|
|
Race (NIH/OMB)
All Patients · American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
All Patients · Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
All Patients · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
All Patients · Black or African American
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
All Patients · White
|
30 Participants
n=30 Participants
|
|
Race (NIH/OMB)
All Patients · More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
All Patients · Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Karnofsky Performance Status (KPS)
KPS Score - 1200 mg/d HCQ · KPS Score of 80
|
11 Participants
n=13 Participants • Indicating Karnofsky Status by HCQ dosage group
|
|
Karnofsky Performance Status (KPS)
KPS Score - 1200 mg/d HCQ · KPS Score of 90
|
1 Participants
n=13 Participants • Indicating Karnofsky Status by HCQ dosage group
|
|
Karnofsky Performance Status (KPS)
KPS Score - 1200 mg/d HCQ · KPS Score of 100
|
1 Participants
n=13 Participants • Indicating Karnofsky Status by HCQ dosage group
|
|
Karnofsky Performance Status (KPS)
KPS Score - 600 mg/d HCQ · KPS Score of 80
|
13 Participants
n=17 Participants • Indicating Karnofsky Status by HCQ dosage group
|
|
Karnofsky Performance Status (KPS)
KPS Score - 600 mg/d HCQ · KPS Score of 90
|
0 Participants
n=17 Participants • Indicating Karnofsky Status by HCQ dosage group
|
|
Karnofsky Performance Status (KPS)
KPS Score - 600 mg/d HCQ · KPS Score of 100
|
4 Participants
n=17 Participants • Indicating Karnofsky Status by HCQ dosage group
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ at either 1,200 mg/d or 600 mg/d) who were evaluable for clinical response. Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dosing was reduced to 600 mg/d.
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=29 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
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Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Progressed Disease - All Patients
|
9 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Stable Disease - All Patients
|
14 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Partial Response - All Patients
|
3 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at Either 1,200 mg/d or 600 mg/d) (All Patients)
Complete Response - All Patients
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) 1,200 mg/d who were evaluable for clinical response.
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=12 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Progressed Disease
|
5 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Stable Disease
|
6 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Partial Response
|
1 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 1,200 mg/d
Complete Response
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) 600 mg/d who were evaluable for clinical response.
Clinical Response: per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=17 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Progressed Disease
|
4 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Stable Disease
|
8 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Partial Response
|
2 Participants
|
|
Clinical Response - IL-2 Combined With Hydroxychloroquine (HCQ) at 600 mg/d
Complete Response
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ).
Time from date of first protocol treatment until the date of death, or censored at date of last contact.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Overall Survival (OS)
|
NA months
Interval 29.6 to
Median and upper limit estimated overall survival in this trial is not yet achieved due to insufficient number of events (deaths).
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients with metastatic RCC treated with IL-2 combined with hydroxychloroquine (HCQ) at either 600 mg/d or 1,200 mg/d.
Time from the date of first protocol treatment until the date disease progression criteria are met (in responding patients progression criteria uses the reference of the smallest measurements recorded since the treatment started) or is censored at date of last disease assessment for those who have not progressed. Per RECIST 1.1, Progressive Disease (PD) is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Progression-free Survival (PFS)
|
5.5 months
Interval 3.0 to 14.0
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Number of doses of IL-2 administered during the first course of therapy.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Number of Doses of IL-2 + HCQ
1200 mg/d HCQ
|
12.8 doses
Interval 9.8 to 15.7
|
|
Number of Doses of IL-2 + HCQ
600 mg/d HCQ
|
13.2 doses
Interval 11.0 to 15.4
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received at least one dose (cycle) of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ) and experienced specified categories of toxicities.
Number of specified categories of grade III and IV or unexpected or rare toxicities occurring during the first course (up until the end of cycle 1) of IL-2 treatment.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Frequency of Grade III and Grade IV Toxicities
Hypotension
|
5 events
|
|
Frequency of Grade III and Grade IV Toxicities
Gastrointestinal
|
1 events
|
|
Frequency of Grade III and Grade IV Toxicities
Hematologic
|
1 events
|
|
Frequency of Grade III and Grade IV Toxicities
Pulmonary
|
1 events
|
|
Frequency of Grade III and Grade IV Toxicities
Renal/electrolytes
|
4 events
|
|
Frequency of Grade III and Grade IV Toxicities
Psychiatric
|
3 events
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Number of participants who experienced Grade 2-5 adverse events.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Worst Grade of Adverse Event Experienced
600 mg/d HCQ · Grade 5 adverse event
|
0 Participants
|
|
Worst Grade of Adverse Event Experienced
1200 mg/d HCQ · Grade 2 adverse event
|
1 Participants
|
|
Worst Grade of Adverse Event Experienced
1200 mg/d HCQ · Grade 3 adverse event
|
4 Participants
|
|
Worst Grade of Adverse Event Experienced
1200 mg/d HCQ · Grade 4 adverse event
|
7 Participants
|
|
Worst Grade of Adverse Event Experienced
1200 mg/d HCQ · Grade 5 adverse event
|
1 Participants
|
|
Worst Grade of Adverse Event Experienced
600 mg/d HCQ · Grade 2 adverse event
|
0 Participants
|
|
Worst Grade of Adverse Event Experienced
600 mg/d HCQ · Grade 3 adverse event
|
4 Participants
|
|
Worst Grade of Adverse Event Experienced
600 mg/d HCQ · Grade 4 adverse event
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Number of participants who experienced Grade 2-5 adverse events that were at least possibly related to study treatment.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
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|---|---|
|
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
1200 mg/d HCQ · Grade 2 adverse event
|
1 Participants
|
|
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
1200 mg/d HCQ · Grade 3 adverse event
|
5 Participants
|
|
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
1200 mg/d HCQ · Grade 4 adverse event
|
7 Participants
|
|
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
600 mg/d HCQ · Grade 2 adverse event
|
0 Participants
|
|
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
600 mg/d HCQ · Grade 3 adverse event
|
4 Participants
|
|
Worst Grade of Adverse Event At Least Possibly Related to Treatment Experienced
600 mg/d HCQ · Grade 4 adverse event
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received at least one dose of study treatment (IL-2 + either 1,200 HCQ or 600 mg/d HCQ).
Number of participants who experienced Grade 2-5 adverse events that were at least probably related to study treatment.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
1200 mg/d HCQ · Grade 2 adverse event
|
1 Participants
|
|
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
1200 mg/d HCQ · Grade 3 adverse event
|
5 Participants
|
|
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
1200 mg/d HCQ · Grade 4 adverse event
|
7 Participants
|
|
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
600 mg/d HCQ · Grade 2 adverse event
|
2 Participants
|
|
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
600 mg/d HCQ · Grade 3 adverse event
|
4 Participants
|
|
Worst Grade of Adverse Event At Least Probably Related to Treatment Experienced
600 mg/d HCQ · Grade 4 adverse event
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Patients that received study treatment for whom LDH was able to be measured from clinical samples and determined to be either normal or high.
Number of participants with either high serum lactate dehydrogenase (\> 1.5 times upper limit of normal) or normal lactate dehydrogenase.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Serum Lactate Dehydrogenase
Normal LDH · 1200 mg/d HCQ
|
11 Participants
|
|
Serum Lactate Dehydrogenase
Normal LDH · 600 mg/d HCQ
|
17 Participants
|
|
Serum Lactate Dehydrogenase
High LDH · 1200 mg/d HCQ
|
2 Participants
|
|
Serum Lactate Dehydrogenase
High LDH · 600 mg/d HCQ
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patient that received study treatment for whom hemoglobin levels were able to be measured from clinical samples and determined to be either normal or low.
Low hemoglobin levels (less than the lower limit of normal (13.2 g/dL)) are considered to be unfavorable.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Hemoglobin Levels
Low hemoglobin level · 1200 mg/d HCQ
|
6 Participants
|
|
Hemoglobin Levels
Low hemoglobin level · 600 mg/d HCQ
|
3 Participants
|
|
Hemoglobin Levels
Normal hemoglobin level · 1200 mg/d HCQ
|
7 Participants
|
|
Hemoglobin Levels
Normal hemoglobin level · 600 mg/d HCQ
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom serum calcium levels were able to be measured from clinical samples and determined to be either normal or high.
Number of patients with either normal or high serum calcium levels. High serum calcium levels are considered to be clinically unfavorable.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Serum Calcium Levels (Corrected)
Normal Calcium · 1200 mg/d HCQ
|
13 Participants
|
|
Serum Calcium Levels (Corrected)
Normal Calcium · 600 mg/d HCQ
|
14 Participants
|
|
Serum Calcium Levels (Corrected)
High Calcium · 1200 mg/d HCQ
|
0 Participants
|
|
Serum Calcium Levels (Corrected)
High Calcium · 600 mg/d HCQ
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment, with or without a history of nephrectomy (surgical removal of a kidney).
Number of patients with history of a prior nephrectomy (surgical removal of a kidney) or no history of a prior nephrectomy.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Prior Nephrectomy
Prior Nephrectomy · 600 mg/d HCQ
|
14 Participants
|
|
Prior Nephrectomy
Prior Nephrectomy · 1200 mg/d HCQ
|
13 Participants
|
|
Prior Nephrectomy
No Prior Nephrectomy · 600 mg/d HCQ
|
3 Participants
|
|
Prior Nephrectomy
No Prior Nephrectomy · 1200 mg/d HCQ
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patient that received study treatment for whom Karnofsky performance status was able to be assessed.
Karnofsky performance status is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient should be included in the trial. A low Karnofsky performance status (\<80%) is considered to be unfavorable.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Number of Participants With Low Karnofsky Performance Status
1200 mg/d HCQ
|
0 Participants
|
|
Number of Participants With Low Karnofsky Performance Status
600 mg/d HCQ
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom Natural Killer (NK) cells were able to be measured.
Percentage of Natural Killer (NK) cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Natural Killer (NK) Cells
|
38.4 percentage of cells
Interval 3.7 to 67.3
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom MDSC were able to be measured.
Percentage of Myeloid Derived Suppressor Cell per ml of blood. MDSC immune cells originate from bone marrow stem cells and strongly expand in cancer.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Myeloid Derived Suppressor Cell (MDSC)
|
11.3 percentage of cells/mL
Interval 4.4 to 23.6
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom Regulatory T cells (Treg) were able to be measured.
Percentage of Regulatory T cells per ml of blood. High levels of Tregs in the tumor microenvironment are associated with poor prognosis in many cancers by suppressing the body's anti-tumor immune response.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Regulatory T Cells (Treg)
|
10.5 percentage of cells/mL
Interval 1.7 to 20.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom Plasmacytoid dendritic Cells (pDC) were able to be measured.
Percentage of Plasmacytoid dendritic cells per ml of blood. In cancer, pDC are malignant immune cells that demonstrate an impaired response that can contribute to the establishment of an immunosuppressive tumor microenvironment.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Plasmacytoid Dendritic Cells (pDC)
|
0.3 percentage of cells/mL
Interval 0.1 to 0.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom T-Cells were able to be measured.
Percentage of T-cell lymphocytes in blood as cells per ml. T-cells are a subtype of white blood cells which play a key role in the immune system and fighting cancer.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
T-cell Lymphocytes
|
63.9 percentage of cells/mL
Interval 17.7 to 80.5
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Patients that received study treatment for whom Conventional Dendritic Cells (cDC) were able to be measured.
Percentage of Conventional Dendritic Cells (cDC) per ml of blood. cDC reside in tissues and once activated, migrate to draining lymph nodes to promote adaptive immune responses.
Outcome measures
| Measure |
Hydroxychloroquine + IL-2
n=30 Participants
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 600 mg/d) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ, but after several unexpected adverse events, dose was reduced to 600 mg/d.
|
|---|---|
|
Conventional Dendritic Cells (cDC)
|
0.6 percentage of cells/mL
Interval 0.0 to 1.5
|
Adverse Events
Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2
Serious events: 12 serious events
Other events: 13 other events
Deaths: 9 deaths
Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
Serious events: 17 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2
n=13 participants at risk
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d (initial (13) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).
|
Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
n=17 participants at risk
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration at 600 mg/d (17 patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Nervous system disorders
Akathisia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Blood bilirubin increased
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
General disorders
Death NOS
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.5%
5/13 • Number of events 8 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 3 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
46.2%
6/13 • Number of events 19 • Up to 3 years for cohort.
|
88.2%
15/17 • Number of events 41 • Up to 3 years for cohort.
|
|
Vascular disorders
Hypotension
|
46.2%
6/13 • Number of events 9 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Investigations
Lipase increased
|
15.4%
2/13 • Number of events 8 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Investigations
Lymphocyte count decreased
|
46.2%
6/13 • Number of events 37 • Up to 3 years for cohort.
|
76.5%
13/17 • Number of events 66 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.7%
1/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Investigations
Platelet count decreased
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Serum amylase increased
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Urinary retention
|
38.5%
5/13 • Number of events 10 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Investigations
Urine output decreased
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
White blood cell decreased
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
Other adverse events
| Measure |
Hydroxychloroquine (HCQ) (1,200 mg/d ) + IL-2
n=13 participants at risk
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration (at 1,200 mg/d (initial (13) patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).
|
Hydroxychloroquine (HCQ) (600 mg/d) + IL-2
n=17 participants at risk
One course of treatment (84 days) will consist of high dose (600,000 IU/kg) bolus IL-2 administered intravenously every 8 hours on days 1-5 and 15-19 (maximum 14 doses/5 days of administration) and hydroxychloroquine (HCQ) orally started two weeks prior to IL-2 infusions and continued while able to take oral medication for up to 3 courses.
Hydroxychloroquine: Continuous oral administration at 600 mg/d (17 patients) was initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
IL-2: 600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
Note: Patients were initially treated at 1200 mg/d HCQ (13 patients), but after several unexpected adverse events, the dose of HCQ was reduced to 600 mg/d (17 patients).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
23.1%
3/13 • Number of events 6 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 3 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Acidosis
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Acute kidney injury
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Agitation
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Nervous system disorders
Akathisia
|
7.7%
1/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Investigations
Alanine aminotransferase increased
|
46.2%
6/13 • Number of events 9 • Up to 3 years for cohort.
|
47.1%
8/17 • Number of events 12 • Up to 3 years for cohort.
|
|
Investigations
Alkaline phosphatase increased
|
61.5%
8/13 • Number of events 26 • Up to 3 years for cohort.
|
35.3%
6/17 • Number of events 16 • Up to 3 years for cohort.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/13 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 3 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Blood and lymphatic system disorders
Anemia
|
61.5%
8/13 • Number of events 41 • Up to 3 years for cohort.
|
76.5%
13/17 • Number of events 50 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Anorexia
|
46.2%
6/13 • Number of events 11 • Up to 3 years for cohort.
|
35.3%
6/17 • Number of events 13 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Anxiety
|
38.5%
5/13 • Number of events 14 • Up to 3 years for cohort.
|
64.7%
11/17 • Number of events 17 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
7.7%
1/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Ascites
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Aspartate aminotransferase increased
|
53.8%
7/13 • Number of events 10 • Up to 3 years for cohort.
|
47.1%
8/17 • Number of events 9 • Up to 3 years for cohort.
|
|
Cardiac disorders
Atrial fibrillation
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
Blood bilirubin increased
|
61.5%
8/13 • Number of events 23 • Up to 3 years for cohort.
|
52.9%
9/17 • Number of events 22 • Up to 3 years for cohort.
|
|
Eye disorders
Blurred vision
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Investigations
CPK increased
|
23.1%
3/13 • Number of events 5 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/13 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
30.8%
4/13 • Number of events 6 • Up to 3 years for cohort.
|
29.4%
5/17 • Number of events 10 • Up to 3 years for cohort.
|
|
Investigations
Cardiac troponin I increased
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
General disorders
Chills
|
69.2%
9/13 • Number of events 16 • Up to 3 years for cohort.
|
47.1%
8/17 • Number of events 17 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Confusion
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Number of events 4 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 5 • Up to 3 years for cohort.
|
41.2%
7/17 • Number of events 7 • Up to 3 years for cohort.
|
|
Investigations
Creatinine increased
|
53.8%
7/13 • Number of events 39 • Up to 3 years for cohort.
|
70.6%
12/17 • Number of events 64 • Up to 3 years for cohort.
|
|
General disorders
Death NOS
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/13 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Diarrhea
|
84.6%
11/13 • Number of events 27 • Up to 3 years for cohort.
|
76.5%
13/17 • Number of events 28 • Up to 3 years for cohort.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 3 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Dry mouth
|
15.4%
2/13 • Number of events 3 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
53.8%
7/13 • Number of events 10 • Up to 3 years for cohort.
|
52.9%
9/17 • Number of events 20 • Up to 3 years for cohort.
|
|
Nervous system disorders
Dysgeusia
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Dyspepsia
|
23.1%
3/13 • Number of events 5 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
76.9%
10/13 • Number of events 15 • Up to 3 years for cohort.
|
41.2%
7/17 • Number of events 8 • Up to 3 years for cohort.
|
|
General disorders
Edema face
|
0.00%
0/13 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
General disorders
Edema limbs
|
69.2%
9/13 • Number of events 19 • Up to 3 years for cohort.
|
58.8%
10/17 • Number of events 18 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Eye disorders
Eye disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
General disorders
Fatigue
|
69.2%
9/13 • Number of events 28 • Up to 3 years for cohort.
|
70.6%
12/17 • Number of events 34 • Up to 3 years for cohort.
|
|
General disorders
Fever
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
41.2%
7/17 • Number of events 23 • Up to 3 years for cohort.
|
|
Eye disorders
Flashing lights
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Vascular disorders
Flushing
|
61.5%
8/13 • Number of events 15 • Up to 3 years for cohort.
|
47.1%
8/17 • Number of events 19 • Up to 3 years for cohort.
|
|
General disorders
Gait disturbance
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 3 • Up to 3 years for cohort.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
61.5%
8/13 • Number of events 18 • Up to 3 years for cohort.
|
52.9%
9/17 • Number of events 18 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Hallucinations
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • Number of events 4 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 5 • Up to 3 years for cohort.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Hematuria
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.7%
1/13 • Number of events 2 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 5 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/13 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
46.2%
6/13 • Number of events 13 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 10 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Vascular disorders
Hypertension
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
61.5%
8/13 • Number of events 61 • Up to 3 years for cohort.
|
82.4%
14/17 • Number of events 77 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
53.8%
7/13 • Number of events 14 • Up to 3 years for cohort.
|
70.6%
12/17 • Number of events 30 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
35.3%
6/17 • Number of events 9 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
84.6%
11/13 • Number of events 28 • Up to 3 years for cohort.
|
94.1%
16/17 • Number of events 48 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
69.2%
9/13 • Number of events 28 • Up to 3 years for cohort.
|
76.5%
13/17 • Number of events 36 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
76.9%
10/13 • Number of events 37 • Up to 3 years for cohort.
|
94.1%
16/17 • Number of events 75 • Up to 3 years for cohort.
|
|
Vascular disorders
Hypotension
|
84.6%
11/13 • Number of events 26 • Up to 3 years for cohort.
|
70.6%
12/17 • Number of events 29 • Up to 3 years for cohort.
|
|
Endocrine disorders
Hypothyroidism
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
INR increased
|
0.00%
0/13 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 5 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Insomnia
|
38.5%
5/13 • Number of events 6 • Up to 3 years for cohort.
|
29.4%
5/17 • Number of events 5 • Up to 3 years for cohort.
|
|
Investigations
Investigations - Other, specify
|
38.5%
5/13 • Number of events 9 • Up to 3 years for cohort.
|
64.7%
11/17 • Number of events 15 • Up to 3 years for cohort.
|
|
Investigations
Lipase increased
|
30.8%
4/13 • Number of events 21 • Up to 3 years for cohort.
|
35.3%
6/17 • Number of events 12 • Up to 3 years for cohort.
|
|
General disorders
Localized edema
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Investigations
Lymphocyte count decreased
|
46.2%
6/13 • Number of events 43 • Up to 3 years for cohort.
|
76.5%
13/17 • Number of events 76 • Up to 3 years for cohort.
|
|
General disorders
Malaise
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
15.4%
2/13 • Number of events 4 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Mucositis oral
|
46.2%
6/13 • Number of events 10 • Up to 3 years for cohort.
|
41.2%
7/17 • Number of events 11 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
15.4%
2/13 • Number of events 3 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Cardiac disorders
Myocarditis
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Nausea
|
92.3%
12/13 • Number of events 30 • Up to 3 years for cohort.
|
82.4%
14/17 • Number of events 40 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Investigations
Neutrophil count decreased
|
15.4%
2/13 • Number of events 3 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 6 • Up to 3 years for cohort.
|
|
General disorders
Non-cardiac chest pain
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Number of events 2 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
General disorders
Pain
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
29.4%
5/17 • Number of events 6 • Up to 3 years for cohort.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 3 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Pancreatitis
|
23.1%
3/13 • Number of events 4 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Nervous system disorders
Paresthesia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Eye disorders
Photophobia
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Investigations
Platelet count decreased
|
61.5%
8/13 • Number of events 25 • Up to 3 years for cohort.
|
70.6%
12/17 • Number of events 45 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Proteinuria
|
46.2%
6/13 • Number of events 8 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 11 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
84.6%
11/13 • Number of events 22 • Up to 3 years for cohort.
|
58.8%
10/17 • Number of events 21 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/13 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 5 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
15.4%
2/13 • Number of events 2 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 5 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
15.4%
2/13 • Number of events 3 • Up to 3 years for cohort.
|
29.4%
5/17 • Number of events 8 • Up to 3 years for cohort.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Investigations
Serum amylase increased
|
30.8%
4/13 • Number of events 18 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 7 • Up to 3 years for cohort.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Cardiac disorders
Sinus tachycardia
|
53.8%
7/13 • Number of events 14 • Up to 3 years for cohort.
|
35.3%
6/17 • Number of events 8 • Up to 3 years for cohort.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
23.5%
4/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/13 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 3 • Up to 3 years for cohort.
|
|
Renal and urinary disorders
Urinary retention
|
46.2%
6/13 • Number of events 12 • Up to 3 years for cohort.
|
29.4%
5/17 • Number of events 10 • Up to 3 years for cohort.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • Up to 3 years for cohort.
|
11.8%
2/17 • Number of events 2 • Up to 3 years for cohort.
|
|
Investigations
Urine output decreased
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/13 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
7.7%
1/13 • Number of events 1 • Up to 3 years for cohort.
|
5.9%
1/17 • Number of events 1 • Up to 3 years for cohort.
|
|
Gastrointestinal disorders
Vomiting
|
69.2%
9/13 • Number of events 21 • Up to 3 years for cohort.
|
64.7%
11/17 • Number of events 25 • Up to 3 years for cohort.
|
|
Investigations
Weight gain
|
38.5%
5/13 • Number of events 6 • Up to 3 years for cohort.
|
47.1%
8/17 • Number of events 12 • Up to 3 years for cohort.
|
|
Investigations
Weight loss
|
15.4%
2/13 • Number of events 3 • Up to 3 years for cohort.
|
17.6%
3/17 • Number of events 4 • Up to 3 years for cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
23.1%
3/13 • Number of events 3 • Up to 3 years for cohort.
|
0.00%
0/17 • Up to 3 years for cohort.
|
|
Investigations
White blood cell decreased
|
38.5%
5/13 • Number of events 8 • Up to 3 years for cohort.
|
35.3%
6/17 • Number of events 13 • Up to 3 years for cohort.
|
Additional Information
Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS
UPMC Hillman Cancer Center
Phone: 412-647-5554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place